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| ID | Type | Description | Link |
|---|---|---|---|
| 3092-51000-061-002S | Other Grant/Funding Number | US Department of Agriculture, Agricultural Research Service |
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| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
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Before infants are born, they depend on their mother to provide the nutrients necessary to grow and develop, such as iron, folic acid, iodine and other vitamins and minerals. Pregnant people also rely on good nutrition to support their own health. In addition to essential nutrients, vitamins, and minerals, there are other natural components found in fruits and vegetables, called phytochemicals, that may support maternal and fetal health during pregnancy.
While more is known about the role of phytochemicals in adult health, surprisingly little is known about phytochemical nutrition during pregnancy. This study focuses on a group of phytochemicals, called carotenoids, during pregnancy.
The study will determine if and why levels of carotenoids in the body change across the course of pregnancy. Understanding carotenoid nutrition during pregnancy will improve the understanding ofnutrition needs of expectant mothers and their infants. To study these questions, both health pregnant and non-pregnant female adults will report on their dietary intake and participate in body measurements, health surveys, and carotenoid measurements of eyes, skin, and blood at time points corresponding with the first, second, and third trimesters of pregnancy as well as post-partum.
What a pregnant person eats is important for their own health and the health of their infant during pregnancy and after birth. Fruits and vegetables contain colorful substances called "carotenoids" which support the nutritional needs of the pregnant person and the infant, may fight inflammation, and may even benefit the person's memory and thinking ability. A person's carotenoid status can be measured with a blood sample and with optical measurements of the skin and eye. What isn't known, is if or why a pregnant person's carotenoid status changes over the course of pregnancy and the early post-partum period, and if those changes have consequences for pregnant person's and infant's health.
The goal of this study is to better understand how and why body levels of carotenoids, change during pregnancy and the post-partum period. We will study whether these changes can be explained by pregnancy, a person's diet, and changes in body composition. We will study if changes in a female's carotenoid status are associated with changes in memory or thinking ability, levels of inflammation, and her infant's carotenoid levels.
Ultimately, this information can guide nutrition advice for future pregnant people.
This study involves 5 study visits for the pregnant or non-pregnant adult female participants with an option to enroll infants for the final, post-partum, visit. For the four follow-up visits, adult participants will have body measurements, will complete surveys, and will provide a blood sample. At the final visit, lactating participants will be asked to provide a milk sample. If enrolled, infant participants will provide an optional blood sample, have body measurements, have an optical skin measurement, and their participating adult guardian will complete an infant eating survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant | Adult females between 18-40 years old who have a confirmed pregnancy. |
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| Non-pregnant | Adult females between 18-40 years old who do not have a confirmed pregnancy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotenoid Intake | Other | Carotenoid intake assess by 24 hour dietary recalls |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Total Carotenoid Concentrations - 1st Trimester Equivalent | Sum of all major carotenoid species in serum collected from fasting participant. | 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant) |
| Serum Total Carotenoid Concentrations - 2nd Trimester Equivalent | Sum of all major carotenoid species in serum collected from fasting participant. | 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant) |
| Serum Total Carotenoid Concentrations - 3rd Trimester Equivalent | Sum of all major carotenoid species in serum collected from fasting participant. | 3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant) |
| Serum Total Carotenoid Concentrations - Post-partum | Sum of all major carotenoid species in serum collected from fasting participant. | Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Carotenoid Concentrations - 1st Trimester Equivalent | Skin carotenoid score measured by pressure-mediated reflection spectroscopy | 1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant) |
| Macular pigment optical density - 1st Trimester Equivalent |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective memory function (MAC-Q Score) - 1st Trimester Equivalent | Subjective memory function assessed by MAC-Q | 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation(Week 0 if non-pregnant) |
| Subjective memory function (MAC-Q Score) - 2nd Trimester Equivalent |
Inclusion Criteria:
Pregnant group
Non-pregnant group
Infants
Exclusion Criteria:
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Healthy adults are recruited from the community of the greater Houston, TX metropolitan area.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine | Houston | Texas | 77030 | United States |
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serum, human milk
| Serum carotenoid concentration | Other | Serum total carotenoid concentration |
|
Macular pigment optical density measured by heterochromatic flicker photometry |
| 1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant) |
| Skin Carotenoid Concentrations - 2nd Trimester Equivalent | Skin carotenoid score measured by pressure-mediated reflection spectroscopy | 2nd Trimester Equivalent: 22 weeks 0d - 23 weeks 6 days gestation (or week 11-12 if non-pregnant) |
| Macular pigment optical density - 2nd Trimester Equivalent | Macular pigment optical density measured by heterochromatic flicker photometry | 2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant) |
| Skin Carotenoid Concentrations - 3rd Trimester Equivalent | Skin carotenoid score measured by pressure-mediated reflection spectroscopy | 3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant) |
| Macular pigment optical density - 3rd Trimester Equivalent | Macular pigment optical density measured by heterochromatic flicker photometry | 3rd Trimester Equivalent: 32 weeks 0 days -33 weeks 6 days weeks gestation (week 22-23 if non-pregnant) |
| Skin Carotenoid Concentrations - Post-partum Equivalent | Skin carotenoid score measured by pressure-mediated reflection spectroscopy | Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
| Macular pigment optical density - Post-partum Equivalent | Macular pigment optical density measured by heterochromatic flicker photometry | Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
Subjective memory function assessed by MAC-Q |
| 2nd Trimester Equivalent: 22 weeks 0 days - 23 weeks 6 days gestation (or week 11-12 if non-pregnant) |
| Subjective memory function (MAC-Q Score) - 3rd Trimester Equivalent | Subjective memory function assessed by MAC-Q | 3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days weeks gestation (week 22-23 if non-pregnant) |
| Subjective memory function (MAC-Q Score) - Post-partum Equivalent | Subjective memory function assessed by MAC-Q | Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
| Serum IL-6 - 1st Trimester Equivalent | Serum concentrations of IL-6 | 1st Trimester Equivalent: 8 weeks 0 days - 13 weeks 6 days gestation (Week 0 if non-pregnant) |
| Serum IL-6 - 2nd Trimester Equivalent | Serum concentrations of IL-6 | 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant) |
| Serum IL-6 - 3rd Trimester Equivalent | Serum concentrations of IL-6 | 3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant) |
| Serum IL-6 - Postpartum Equivalent | Serum concentrations of IL-6 | Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
| Serum hsCRP - 1st Trimester Equivalent | Serum concentrations of high sensitivity C-reactive protein | 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant) |
| Serum hsCRP - 2nd Trimester Equivalent | Serum concentrations of high sensitivity C-reactive protein | 2nd Trimester Equivalent: 22w0d-23w6d gestation (or week 11-12 if non-pregnant) |
| Serum hsCRP - 3rd Trimester Equivalent | Serum concentrations of high sensitivity C-reactive protein | 3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant) |
| Serum hsCRP - Postpartum Equivalent | Serum concentrations of high sensitivity C-reactive protein | Post-partum Equivalent: 7 weeks 0 days-8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
| Serum sTNFr-II - 1st Trimester Equivalent | Serum concentrations of sTNFr-II | 1st Trimester Equivalent: 8 weeks 0 days-13 weeks 6 days gestation (Week 0 if non-pregnant) |
| Serum sTNFr-II - 2nd Trimester Equivalent | Serum concentrations of sTNFr-II | 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant) |
| Serum sTNFr-II - 3rd Trimester Equivalent | Serum concentrations of sTNFr-II | 3rd Trimester Equivalent: 32 weeks 0 days-33 weeks 6 days gestation (week 22-23 if non-pregnant) |
| Serum sTNFr-II - Post-partum Equivalent | Serum concentrations of sTNFr-II | Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
| Serum TNF-alpha- 1st Trimester Equivalent | Serum concentrations of sTNF-alpha | 1st Trimester Equivalent: 8 weeks 0 days -13 weeks 6 days gestation (Week 0 if non-pregnant) |
| Serum TNF-alpha- 2nd Trimester Equivalent | Serum concentrations of sTNF-alpha | 2nd Trimester Equivalent: 22 weeks 0 days-23 weeks 6 days gestation (or week 11-12 if non-pregnant) |
| Serum TNF-alpha- 3rd Trimester Equivalent | Serum concentrations of sTNF-alpha | 3rd Trimester Equivalent: 32 weeks 0 days - 33 weeks 6 days gestation (week 22-23 if non-pregnant) |
| Serum TNF-alpha- Post-partum Equivalent | Serum concentrations of sTNF-alpha | Post-partum Equivalent: 7 weeks 0 days - 8 weeks 6 days post-partum (weeks 36-37 if non pregnant) |
| Infant serum carotenoid concentration | Serum total carotenoid concentration in 7-8 week old infants | 7 weeks 0 days - 8 weeks 6 days post-partum |
| Infant serum carotenoid concentration | Serum total carotenoid concentration in 7-8 week old infants | Post-partum: 7 weeks 0 days - 8 weeks 6 days post-partum |